← Eichor
Study identifier: NCT03844061 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis

Condition: Systemic Sclerosis  ·  Sponsor: Hospital for Special Surgery, New York

PhasePhase 2
Planned participants30
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNo

About this study

This is a 52 week, single center, randomized, double-blind, placebo-controlled study. After patients maintain a stable dose of Mycophenolate Mofetil (MMF) for at least 1 month, they will be randomized to treatment with either Belimumab \& Rituximab or placebo.Patients in both groups will be on background MMF for the entirety of the study. Belimumab will be administered subcutaneously and Rituximab intravenously. Placebo injections and infusions will be of normal saline. Randomization will be done in a 2:1 manner to favor the treatment group. It is hypothesized that that Rituximab and Belimumab combination therapy with Mycophenolate Mofetil background therapy will improve fibrosis in SSc skin when compared to treatment with placebo and Mycophenolate Mofetil in a group of patients with early dcSSc.

This description comes directly from the study's public registry record.

Talk to the study team

Liza Morales  ·  212-774-2048  ·  moralesli@hss.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Hospital for Special SurgeryNew York, New York, United StatesRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT03844061